2013-2015年温州市耐多药肺结核患者队列标准化疗方案的治疗转归

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目的 研究温州市耐多药肺结核患者队列标准化疗方案的治疗转归,并分析其影响因素.方法 搜集2013年8月至2015年12月筛查确诊的耐多药肺结核患者198例,其中,10例患者拒绝接受治疗,3例患者治疗前已死亡,2例患者治疗前已失访,43例患者化疗方案及转归不详,1例患者基线临床分离菌株经药物敏感性试验(简称“药敏试验”)复核对一线抗结核药物均敏感,7例基线菌株经16S rRNA和hsp65基因测序鉴定为非结核分枝杆菌(NTM),16例为非标准化耐多药肺结核化疗方案,最终纳入耐多药肺结核标准化疗方案治疗的患者有116例.记录上述患者的基线临床特征、药敏试验结果和随访时痰培养阴转情况、症状改善情况及影像学变化,判定最终治疗的转归情况.结果 耐多药肺结核纳入标准化疗方案治疗的116例患者中,初治39例(33.6%)、复治77例(66.4%);男83例(71.6%)、女33例(28.4%);年龄范围15~77岁,平均年龄(48.7±12.6)岁.治疗成功59例(50.9%)、治疗失败19例(16.4%)、死亡5例(4.3%)、失访33例(28.4%).初治患者治疗成功率(69.2%,27/39)高于复治患者(41.6%,32/77),差异有统计学意义(x2=7.932,P=0.005).单纯MDR-TB患者治疗成功率(67.7%,21/31)高于早期广泛耐药结核病(pre-XDR-TB)患者(42.6%,20/47)和XDR-TB患者(15.4%,2/13),差异均有统计学意义(分别为x2 =4.753,P=0.029和x2=10.064,P=0.002).单纯MDR-TB患者失访率(25.8%,8/31)分别与pre-XDR-TB患者(27.7%,13/47)和XDR-TB患者(23.1%,3/13)比较,差异均无统计学意义(分别为x2 =0.033,P=0.857和x2=0.036,P=0.849).对91例MDR-TB患者基线菌株进行二线抗结核药物的药敏试验结果显示,单纯MDR-TB、pre-XDR-TB和XDR-TB分别占34.1%(31/91)、51.6%(47/91)和14.3%(13/91),其中对Ofx耐药的患者占63.7%(58/91).单纯MDR-TB患者痰菌阴转率(87.1%,27/31)高于pre-XDR-TB患者(66.0%,31/47)和XDR-TB患者(38.5%,5/13),差异有统计学意义(log-rank趋势检验,x2=14.500,P<0.001).结论 温州市耐多药肺结核治疗成功率较低,可能与基线pre-MDR-TB和XDR-TB所占比率及失访率较高有关.“,”Objective To study the treatment outcomes of multidrug-resistant pulmonary tuberculosis and analyze the factors associated with treatment outcome in Wenzhou.Methods Data of 198 MDR-TB patients diagnosed from August 2013 to December 2015 were retrospectively collected.Among them,10 patients refused to accept treatment,3 patients died and 2 patients were lost to follow-up before treatment,the chemotherapy regimens and treatment outcomes of 43 patients were unknown,the baseline strain of 1 patient was confirmed as sensitive by the drug sensitivity test three times,the baseline strains of 7 patients were identified as non-tuberculous mycobacteria by 16S rRNA and hsp65 gene,and 16 patients received non-standardized multidrug-resistant tuberculosis regimens.Finally 116 patients received standardized regimens for MDR-TB.We recorded their baseline clinical characteristics,baseline drug susceptibility results,sputum culture conversion,clinical symptom and imaging changes.The primary endpoint was cure,treatment completed,treatment failure,death,or default (lost to follow-up) at the end of the treatment period.Results Of 116 patients enrolled into the standardized regimens for MDR-TB,the number of new patients and previously treated patients were 39 (33.6%) and 77 (66.4%),respectively.There were 83 male patients accounting for 71.6% and 33 female patients accounting for 28.4%.The average age was (48.7 ± 12.6) years old and the age ranged from 15 to 77 years old.Of the 116 MDR-TB patients,59 (50.9%) were cured or completed treatment,19 (16.4%) experienced treatment failure,5 (4.3%) died,and 33 (28.4%) were lost to follow-up.The success rate of new patients was higher than that of previously treated patients (69.2% vs 41.6%),and the difference was statistically significant (x2 =7.932,P =0.005).The success rate of MDR-TB (67.7 %,21/31) was higher than that of pre-XDR-TB (42.6%,20/47) and XDR-TB (15.4%,2/13),the differences were statistically significant (x2 =4.753,P =0.029 and x2 =10.064,P =0.002).The loss rate of MDR-TB (25.8 %,8/31) was respectively compared with that of pre-XDR-TB (27.7%,13/47) and XDRTB (23.1%,3/13),while there was no statistically significant difference among them (x2 =0.033,P=0.857;x2 =0.036,P=0.849).Of the 91 patients with baseline second-line drug susceptibility,34.1% (31/91),51.6% (47/91) and 14.3% (13/91),respectively,was simple MDR-TB,pre-XDR-TB,and XDR-TB.And the resistant proportion of ofloxacin accounted for 63.7% (58/91).Simple MDR-TB (87.1%,27/31) was higher than the pre-XDR-TB (66.0%,31/47) and XDR-TB (38.5%,5/13) in terms of sputum culture conversion rates,the difference were statistically significant (log-rank trend test,x2=14.500,P<0.001).Conclusion The low success rates of MDR-TB treatment in Wenzhou may be related to the high proportion of Pre-XDR-TB and XDR-TB and the high default rates.
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